ABSTRACT
En este trabajo, fue desarrollado y validado un método indicador de estabilidad por cromatografía líquida, para ser aplicado al estudio cinético de Rosuvastatina Cálcica en diferentes valores de pH y temperatura. Las condiciones cromatográficas seleccionadas fueron: columna C18, 50 x 4.6 mm y 3,5 µm de tamaño de partícula; fase móvil MeOH: Agua-0.1%TFA, temperatura de la columna de la columna 25 ° C, y velocidad de flujo 1 mL/min. El método validado presentó una adecuada repetibilidad y precisión intermedia y una recuperación superior al 98%. Por otra parte, el método fue lineal en el rango de 10 a 150 ppm. En condiciones ácidas, fueron identificados tres posibles productos de degradación como: Rosuvastatina Lactona, Rosuvastatina Anti-isómero y Rosuvastatina Lactona Anti-isómero y en condiciones de degradación con la luz se identificaron dos posibles productos mayoritarios. El método validado puede ser empleado en estudios de estabilidad y de degradación cinética del fármaco.
In this work, a liquid chromatography stability-indicating method was development and validated to be applied at study the hydrolytic behavior of Rosuvastatin Calcium in different pH values and temperatures. The selected chromatographic conditions were a column C18 50 x 4.6 mm and 3.5 µm. The mobile phase was Methanol: Water-1%TFA; 25°C column temperature and flow rate 1 mL/min. The validation method exhibited an adequate repeatability and intermediate precision and a recovery higher than 98%. Furthermore, the method was lineal in range of 10 to 150 ppm. Under acidic conditions, three degradation products possible were identified as Rosuvastatin lactone, Rosuvastatin anti-isomer and Rosuvastatin lactone anti-isomer, with light were identified two major decomposition products. The validated method can be used in the stability studies and drug degradation kinetics.
ABSTRACT
Objective To investigate thermal degradation kinetic characteristics of Cefmenoxime Hydrochloride in infusion solutions, and predict its thermal stability. Methods The HPLC was applied to determine the contents of Cefmenoxime Hydrochloride. Classical isothermal kinetic method and multivariate linear model were used to predict the expiration date of the injection. Results It was found that the thermal degradation kinetics of Cefmenoxime Hydrochloride in two infusion solutions corresponded with the first-order kinetics. The expiration dates of Cefmenoxime Hydrochloride in 0. 9%sodium chloride injection calculated by two different methods were 2. 20 days and 1. 52 days,and in 5% glucose injection were 2. 09 days and 1. 53 days,respectively. Conclusion The thermal stability of Cefmenoxime Hydrochloride in infusion solutions is poor and its expiration dates are the same calculated by two different methods.